drugset / Trial / NCT04724460
Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary purpose of this study is to determine the optimal duration of anticoagulation therapy (6 months versus 18 months) with direct oral anticoagulant (DOAC) for cancer-associated low-risk pulmonary embolism patients. The major secondary purpose of this study is to investigate whether home treatment of cancer-associated low-risk pulmonary embolism patients with rivaroxaban is feasible, effective, and safe through an observational management study.
Timeline
- Start
- 2021-02-18
- Primary completion
- 2024-09-27
- Completion
- 2024-12-31
Publications
- Nagai T, Nakanishi N, Yamashita Y, Morimoto T, Hiramori S, Chatani R, Nishimoto Y, Ikeda N, Kobayashi Y, Ikeda S, Kim K, Shiba M, Takase T, Tsuji S, Oi M, Takada T, Otsui K, Sakamoto J, Ogihara Y, Inoue T, Usami S, Chen PM, Togi K, Koitabashi N, Doi K, Mabuchi H, Tsuyuki Y, Murata K, Takabayashi K, Nakai H, Sueta D, Shioyama W, Dohke T, Kimura T, Matoba S; COMMAND VTE Registry-2 Investigators. A Bleeding Risk Score for Cancer-Associated Venous Thromboembolism in Patients Receiving Direct Oral Anticoagulants. JACC CardioOncol. 2026 Jun;8(3):281-295. doi: 10.1016/j.jaccao.2026.05.002.
- Xiong W, Yamashita Y, Morimoto T, Muraoka N, Shioyama W, Nakagawa Y, Chatani R, Yamamoto H, Shibata T, Morikawa N, Fukumoto Y, Nishimoto Y, Ono K, Kimura T; ONCO PE Trial Investigators. Extended Anticoagulation Therapy With Rivaroxaban for Cancer-Associated Low-Risk Pulmonary Embolism According to Different Performance Status Scores: Insights From the ONCO PE Randomized Trial. J Am Heart Assoc. 2026 Mar 17;15(6):e045541. doi: 10.1161/JAHA.125.045541. Epub 2026 Feb 27.
- Yamashita Y, Morimoto T, Muraoka N, Shioyama W, Chatani R, Shibata T, Nishimoto Y, Ogihara Y, Doi K, Oi M, Shiga T, Sueta D, Kim K, Tanabe Y, Koitabashi N, Takada T, Ikeda S, Nakagawa H, Tsukahara K, Shoji M, Sakamoto J, Hisatake S, Ogino Y, Fujita M, Nakanishi N, Dohke T, Hiramori S, Nawada R, Kaneda K, Ono K, Kimura T; ONCO PE Trial Investigators. Rivaroxaban for 18 Months Versus 6 Months in Patients With Cancer and Acute Low-Risk Pulmonary Embolism: An Open-Label, Multicenter, Randomized Clinical Trial (ONCO PE Trial). Circulation. 2025 Mar 4;151(9):589-600. doi: 10.1161/CIRCULATIONAHA.124.072758. Epub 2024 Nov 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rivaroxaban | Other / unclassified | — | Oral |